Endometriosis is an estrogen-dependent inflammatory disease, affecting almost 5% of the
female population during the reproductive period. The most common symptom of women with
endometriosis is dysmenorrhea. Nowadays, the main therapy is pharmacological treatment
(estrogen-progestins and progestins); diet and physical exercises may represent a
complementary and feasible approach to reduce the pain symptoms related to this disease.
Indeed, diet may be involved in several pathophysiological mechanisms linked to
endometriosis, due to its ability to influence positively or negatively prostaglandins'
metabolism, chronic inflammatory processes and circulating estrogen levels.
Among the various dietary regimes, the Mediterranean diet shows many anti-inflammatory
and anti-oxidant properties.
Also regular physical activity can affect positively endometriosis, due to various
etiopathogenetic mechanisms including the decrease of estrogenic levels and ovulatory
frequency, the increase in SHBG levels, and the modulation of cytokines in an
anti-inflammatory way.
One of the reasons of low regular physical activity is the lack of free time. For this
reason, the American College of Sports Medicine developed a program designed for most of
the population, called "7-minutes workout". It consists in 12 high-intensity physical
exercises, lasting 30 seconds each and spaced out 10 seconds of short breaks, to be
performed 2-3 times a week.
Currently, there are few studies evaluating the impact of regular physical activity and
Mediterranean diet regimen on endometriosis.
The objective of this randomized controlled trial is to evaluate the potential beneficial
impact of regular aerobic physical activity and Mediterranean diet on endometriosis pain
symptoms.
Eligible women will be selected among those attending the Endometriosis Clinic of the "L.
Mangiagalli ", IRCCS Ca 'Granda Foundation and Ospedale Maggiore Policlinico, and will be
randomized into two homogeneous groups ("intervention" and "control") with a 1:1 ratio,
according to the type of therapy: estro-progestins or progestins.
The "intervention" group will be composed of women with symptomatic endometriosis in
estro-progestins or only progestin therapy, who will be asked to follow a Mediterranean
diet and to practice a regular exercise program according to the "7-minutes workout"
model. The "control" group will be composed of women with symptomatic endometriosis under
therapy with estro-progestins or progestins who will continue to receive the routine
clinical care.
All patients participating in the study will undergo clinical and ultrasonographic
evaluation every fourth months. On these occasions, women will be routinely asked to
complete some questionnaires, one on pain (a numerical rating scale, NRS), one on quality
of life (the Short Form-12 questionnaire, SF-12), one on psychological status (the
Hospital Anxiety and Depression scale, HADS), one on sexual functioning (theFemale Sexual
Function Index, FSFI) and one on the global impression of change (Patients' Global
Impression of Change scale, PGIC). Women will be also asked to rate the degree of
satisfaction with their treatment. Moreover, at the beginning and at the end of the study
all participants will be asked to complete a dietary questionnaire, a physical activity
questionnaire (International Physical Activity Questionnaire, IPAQ) and a sleep quality
questionnaire (The Pittsburgh Sleep Quality Index, PSQI).
Only the patients in the "intervention" group will be asked to follow a Mediterranean
diet. They will receive a nutritional counseling with the investigator's hospital
dietician periodically. Furthermore, these patients will follow an aerobic physical
activity program 2-3 times a week for one year.
